MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number MICL12.6

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Loss of Vision (2139); No Code Available (3191)

Event Type  Injury  

Event Description

Additional information received - the facility indicated at a post-op visit on (b)(6) 2015 the patient's vision was plano 20/20 ou.The lens was vaulted more forward in the right eye than left but the patient is happy and seeing great.

Manufacturer Narrative

Evaluation method: medical review.Results: per medical review - reportedly, by a person from the facility, following immediate icl implantation the patient did not achieve uncorrected visual acuity she was expecting.The iop was not elevated.At the five-week follow-up , email was received from the same person from the facility, stating that patient status improved and va was 20/20 uncorrected.According to that email the most likely cause of the event was not device related.The event was caused by medication (unknown artificial tears).Upon the patient stopped taking artificial tears, the visual acuity improved.It is well known that some artificial tears may cause blurred vision.She was very happy with the results.Conclusions: based on the complaint history, work order search and the medical review, the event was caused by medication (unknown artificial tears).(b)(4).

Event Description

The reporter stated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens in the patient's left eye (os) on (b)(6) 2014.The reporter stated the patient has a refractive surprise.The lens is 20/60 -1.50, the lens vault is 250um, intraocular pressure is mid-teens and eyes are only mildly dry.The lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

(b)(4) - no code available (refractive surprise); vision, loss of; (implanted).Device evaluated by manufacturer? no.Lens remains implanted.Evaluation method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Conclusions - (no conclusion can be drawn): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4361935
• MDR Text Key: 15357329
• Report Number: 2023826-2014-01149
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: MICL12.6
• Other Device ID Number: DIOPTER -5.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INJECTOR MODEL AND LOT NUMBER UNK; CARTRIDGE MODEL AND LOT NUMBER UNK
• Patient Age: 23 YR